MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 3-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z316H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: - what does 'f000102563' refers to from product vcpb977h?=>'f000102563' is the ickit lot number.- please provide the lot number of vcpb977h.=>unk - please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).=>(b)(4).H3 investigation summary: the product received for analysis was z316h visual inspection and metallurgical analysis were performed on the returned product.A failed suture needle, labeled as (b)(4)., was submitted to herrera, stafford and associates, llc (hsa) for fractographic evaluation on december 10, 2025.The component was identified as product code vcpb977h.It was requested that hsa assess the fracture mode of the failure.A fracture was observed at the suture attachment of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of (b)(4).Revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.
Event or Problem Description
It was reported that a patient underwent a c-section procedure on an unknown date and suture was used.During the procedure, it was reported by a sales rep that, during a caesarean section (c-section), one package of vcpb977h in ickit had a knot on the suture.And after opening the package of z316h, the needle and thread had already detached, so the customer stopped using these two products and took out a new suture.It was not a control release needle.No sample will be returned.Lot number - f000102563 (product code: vcpb977h) - unknown if this is the correct lot number.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 3-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24641838
• Report Number: 2210968-2026-02817
• Device Sequence Number: 15926451
• Product Code: NEW
• UDI-Device Identifier: 10705031060470
• UDI-Public: (01)10705031060470(17)291231(10)105TZ6
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: Z316H
• Device Lot Number: 105TZ6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown